Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Linking Epidermal Barrier Function With Anti-Oxidant Defense Mechanisms in Skin Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03198390
Recruitment Status : Recruiting
First Posted : June 26, 2017
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
University of Arizona

Tracking Information
First Submitted Date June 13, 2017
First Posted Date June 26, 2017
Last Update Posted Date June 26, 2019
Actual Study Start Date August 4, 2017
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 22, 2017)
  • Skin barrier function [ Time Frame: 1 hour ]
    Transepidermal water loss (TEWL) status will be measured using hand-held, noninvasive, skin barrier measuring device (Tewameter).
  • Skin barrier function [ Time Frame: 1 hour ]
    Stratum corneum hydration status will be measured using hand-held, noninvasive, skin barrier measuring device (Moisturemeter/Corneometer)
  • Skin pH [ Time Frame: 1 hour ]
    Skin pH will be measured using a pH meter.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03198390 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Linking Epidermal Barrier Function With Anti-Oxidant Defense Mechanisms in Skin Conditions
Official Title Linking Epidermal Barrier Function With Anti-Oxidant Defense Mechanisms in Skin Conditions
Brief Summary Investigators will sample the skin and blood of patients with chronic skin conditions (including but not limited to atopic dermatitis (AD), contact dermatitis, hidradenitis suppurativa (HS), and psoriasis) to study the expression of anti-oxidative enzymes, skin barrier proteins and inflammatory molecules. In patients with atopic dermatitis, investigators will also measure skin barrier function using noninvasive devices. These results will be correlated with the disease severity in atopic dermatitis patients.
Detailed Description

Up to 300 subjects with chronic skin conditions (including but not limited to atopic dermatitis (AD), contact dermatitis, hidradenitis suppurativa (HS), and psoriasis) and 100 healthy subjects meeting the inclusion criteria will be enrolled. Medical records will be reviewed pertaining to the subject's diagnosed chronic skin condition and specific therapeutic interventions.

For atopic dermatitis subjects, AD severity will be assessed using Eczema Area and Severity Index (EASI). Study sites will be chosen by the investigator. One lesional and one nonlesional site on the trunk, upper, or lower extremities will be selected. Digital photos of the study skin site(s) will be taken. Skin barrier function indices (transepidermal water loss, pH, sebum and hydration levels) of an active lesion and adjacent nonlesional skin will be measured using noninvasive skin barrier measurement devices.

For subjects with other chronic skin conditions such as contact dermatitis, HS or psoriasis, photos of the selected study sites will be taken. No skin barrier measurements will be performed.

For all subjects, two 3mm punch biopsies will be performed over the selected skin sites. One biopsy will be performed over an active lesion and another on adjacent nonlesional skin. Tissue will be sent out for immunohistochemical staining to study the expression anti-oxidant biomarkers. Five mL of peripheral venous blood will be collected for immunoassay to measure the level inflammatory cytokines.

For healthy subjects, digital photo of the study skin site(s) over either the trunk, upper, or lower extremities will be taken. Skin barrier function indices (transepidermal water loss, pH, sebum and hydration levels) of skin be measured using noninvasive skin barrier measurement devices. One 3mm punch biopsy will be performed over the same skin site that skin barrier measurements were performed. Tissue will be sent out for immunohistochemical staining to study the expression anti-oxidant biomarkers. Five mL of peripheral venous blood will be collected for immunoassay to measure the level inflammatory cytokines.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Male and female, from 18 to 99 years of age.Adult subjects must be able to comprehend and read the English language. Subjects diagnosed with chronic skin conditions or with healthy skin defined as without clinical evidence or diagnosis of inflammatory skin conditions. Subjects with chronic skin conditions must have at least one active skin lesion.
Condition
  • Atopic Dermatitis
  • Hidradenitis Suppurativa
  • Contact Dermatitis
  • Psoriasis
Intervention Not Provided
Study Groups/Cohorts
  • Subjects with chronic skin conditions
    Subjects with chronic skin conditions including but not limited to atopic dermatitis, contact dermatitis, hidradenitis suppurativa, and psoriasis
  • Healthy subjects
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 22, 2017)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 1, 2021
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Male and female 18 to 99 years of age. Chronic skin conditions (including but not limited to atopic dermatitis, contact dermatitis, hidradenitis suppurativa, and psoriasis) with at least one active skin lesion Healthy skin (defined no clinical evidence or diagnosis of inflammatory skin conditions)

Exclusion Criteria:

Subjects who are unable to comply with study procedures.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: UA Dermatology Clinical Trials Unit 520-694-1828 uadermatologyresearch@gmail.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03198390
Other Study ID Numbers 1705434989
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Arizona
Study Sponsor University of Arizona
Collaborators Not Provided
Investigators Not Provided
PRS Account University of Arizona
Verification Date June 2019